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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02517775
Other study ID # 14-012
Secondary ID
Status Completed
Phase N/A
First received July 8, 2015
Last updated November 2, 2015
Start date October 2014
Est. completion date September 2015

Study information

Verified date November 2015
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk has shown promising results. However, to date, very few human studies have specifically investigated the effects of cranberry (poly)phenols on cardiovascular function in healthy subjects. To our knowledge, no study has investigated the time and intake-dependent effect of cranberry consumption on vascular function in healthy subjects. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of cranberries, using optimal amounts at optimal time points. Therefore, this study aims to investigate the potential role of cranberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma and urine.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- healthy male subjects without clinical signs or symptoms of cardiovascular disease

Exclusion Criteria:

- cardiovascular disease

- acute inflammation

- cardiac arrhythmia

- renal failure

- heart failure (NYHA II-IV)

- diabetes mellitus

- C-reactive protein > 05 mg/dL

- malignant disease

- cranberry allergy/intolerance

- hypotension (=100 / 60 mm Hg)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Cranberry 320
Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry 640
Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry 960
Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry 1280
Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry 1600
Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)
Cranberry deprived supplement
Cranberry deprived supplement Acute intake of 500 mL (1x daily)

Locations

Country Name City State
Germany Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf Duesseldorf

Sponsors (2)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf The Cranberry Institute

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Plasma (poly)phenol metabolites measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0,1, 2, 4, 6, 8 and 24 hours after intake Baseline, on week 1, 2, 3, 4 and 5 postconsumption No
Other Urinary (poly)phenol metabolites measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS) at 0, 8 and 24 hours after intake Baseline, on week 1, 2, 3, 4 and 5 postconsumption No
Primary Endothelial function measured by Flow mediated dilation at 1, 2, 4, 6 and 8 hours after intake Baseline, on week 1, 2, 3, 4 and 5 postconsumption No
Secondary pulse wave velocity measured by SphygmoCor at 0, 1, 2, 4, 6 and 8 hours after intake Baseline, on week 1, 2, 3, 4 and 5 postconsumption No
Secondary Central blood pressure measured by SphygmoCor at 0, 1.5, 4, 6 and 8 hours after intake Baseline, on week 1, 2, 3, 4 and 5 postconsumption No
Secondary Peripheral blood pressure measured by automatic sphygmomanometer at 0, 1, 2, 4, 6 and 8 hours after intake Baseline, on week 1, 2, 3, 4 and 5 postconsumption No
Secondary Heart Rate measured by SphygmoCor 0, 1, 2, 4, 6 and 8 hours after intake Baseline, on week 1, 2, 3, 4 and 5 postconsumption No
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